Method and apparatus for indication-based programming of cardiac rhythm management devices

ABSTRACT

A cardiac rhythm management (CRM) system includes a programming device that determines parameters for programming an implantable medical device based on patient-specific information including indications for use of the implantable medical device. By executing an indication-based programming algorithm, the programming device substantially automates the process between the diagnosis of a patient and the programming of an implantable medical device using parameters individually determined for that patient.

CROSS-REFERENCE TO RELATED APPLICATION

This application is a continuation of U.S. patent application Ser. No.14/255,877, filed Apr. 17, 2014, which is a continuation of U.S. patentapplication Ser. No. 11/831,683, filed Jul. 31, 2007, which is acontinuation of U.S. patent application Ser. No. 11/110,500, filed Apr.20, 2005, now issued as U.S. Pat. No. 7,257,447, each of which is herebyincorporated by reference in its entirety.

This application is related to co-pending, commonly assigned, U.S.patent application Ser. No. 10/950,876, entitled “SYSTEM AND METHOD FORDETERMINING PATIENT-SPECIFIC IMPLANTABLE MEDICAL DEVICE PROGRAMMINGPARAMETERS,” filed on Sep. 27, 2004, now issued as U.S. Pat. No.8,285,378, and U.S. patent application Ser. No. 10/844,642, entitled“METHOD AND APPARATUS FOR QUESTION-BASED PROGRAMMING OF CARDIAC RHYTHMMANAGEMENT DEVICES,” filed on May 13, 2004, now issued as U.S. Pat. No.7,697,993, which are hereby incorporated by reference in their entirety.

FIELD OF THE INVENTION

This document generally relates to cardiac rhythm management (CRM)systems and particularly, but not by way of limitation, to a system forprogramming implantable CRM devices.

BACKGROUND

Implantable CRM devices such as pacemakers and defibrillators are usedto treat cardiac arrhythmias, heart failure, and other cardiac disordersby delivering electrical energy to the heart. Advances in biomedicaltechnology have provided implantable CRM devices with increasinglysophisticated features and operational modes treating more types ofdisorders while being more adaptive to a patient's changingphysiological conditions and individual lifestyle. As a consequence,programming an implantable CRM device is an increasingly complicatedtask. To maximize the extent to which the patient can potentiallybenefit from the implantable CRM device, the programming needs to besubstantially patient-specific.

To operate after implantation into a patient, an implantable CRM deviceis programmed by a physician or other caregiver using an externalprogramming device. The programming device allows the physician or othercaregiver to program the implantable CRM device by entering or selectingvalues for programmable parameters. Such programmable parametersinclude, but are not limited to, therapy modes and quantitativeparameters required for operating in each therapy mode, special featuresand quantitative parameters required for utilizing each special feature,and various therapy activation or feature activation criteria. Theseparameters are determined by the physician or other caregiver for eachpatient based on the patient's indications for use of the implantableCRM device as well as other patient-specific data obtained duringvarious diagnoses and tests. The increasing number of programmableparameters that accompany the increasingly sophisticated features andoperational modes makes the parameter determination increasinglydifficult. Additionally, implantable CRM devices of different types, aswell as some devices of the same type, require different programmableparameters and/or different programming procedures. Physicians and/orother caregivers may have to receive extensive training on how toprogram each specific type of implantable CRM devices for an individualpatient and how to optimally utilize many advanced features for thebenefit of that patient. Introductions of new device features, whileproviding the users with additional power in treating cardiac disorders,tend to make the programming of implantable CRM devices more difficultand intimidating. One undesirable consequence is underutilization ofavailable device features and capabilities. If properly utilized, suchunderutilized device features and capabilities will potentially providesubstantial additional benefits to many patients who have alreadybenefited from implantable CRM devices.

For these and other reasons, there is a need for facilitating theprocess of optimally programming an implantable CRM device for eachindividual patient.

SUMMARY

A CRM system includes a programming device that determines parametersfor programming an implantable medical device based on patient-specificinformation including indications for use of the implantable medicaldevice. By executing an indication-based programming algorithm, theprogramming device substantially automates the process between thediagnosis of a patient and the programming of an implantable medicaldevice using parameters individually determined for that patient.

In one embodiment, an external system for programming an implantablemedical device includes an external telemetry circuit and anindication-based programming device. The external telemetry circuitcommunicates with the implantable medical device. The indication-basedprogramming device includes a patient information input, a deviceinformation input, an indication-based parameter generation module, anda programming module. The patient information input receivespatient-specific information including indications for use of theimplantable medical device. The device information input receivesdevice-specific information including a device type indicative of aplurality of programmable parameters. The indication-based parametergeneration module produces values for a set of operational parameters ofthe plurality of programmable parameters based on the patient-specificinformation and the device-specific information. The programming moduleprograms the implantable medical device using the values of the set ofoperational parameters.

In a further embodiment, a cardiac rhythm management (CRM) systemincludes the external system and an implantable medical device. Theimplantable medical device is identified by a device type indicative ofone or more available operational modes and a plurality of programmableparameters.

In one embodiment, a method for programming an implantable medicaldevice is provided. Patient-specific information including indicationsfor use of the implantable medical device is collected. Device-specificinformation including a device type of the implantable medical device isreceived. The device type indicates one or more available operationalmodes and a plurality of programmable parameters of the implantablemedical device. An indication-based programming algorithm is executed toproduce values for a set of operational parameters of the plurality ofprogrammable parameters based on the patient-specific information andthe device-specific information. A user election is received todetermine whether to accept, modify, or discard the values for the setof operational parameters.

This Summary is an overview of some of the teachings of the presentapplication and not intended to be an exclusive or exhaustive treatmentof the present subject matter. Further details about the present subjectmatter are found in the detailed description and appended claims. Otheraspects of the invention will be apparent to persons skilled in the artupon reading and understanding the following detailed description andviewing the drawings that form a part thereof. The scope of the presentinvention is defined by the appended claims and their legal equivalents.

BRIEF DESCRIPTION OF THE DRAWINGS

In the drawings, which are for illustrative purposes only and notnecessarily drawn to scale, like numerals describe similar componentsthroughout the several views. The drawings illustrate generally, by wayof example, various embodiments discussed in the present document.

FIG. 1 is an illustration of an embodiment of a CRM system and portionsof the environment in which the CRM system is used.

FIG. 2 is a block diagram illustrating an embodiment of portions of thecircuit of an external system performing indication-based programming ofan implantable medical device.

FIG. 3 is a block diagram illustrating a specific embodiment of portionsof the circuit of the external system.

FIG. 4 is a block diagram illustrating an embodiment of the externalsystem.

FIG. 5 is a flow chart illustrating an embodiment of a method forindication-based programming of an implantable medical device.

FIG. 6 is a flow chart illustrating a specific embodiment of the methodfor indication-based programming of the implantable medical device.

DETAILED DESCRIPTION

In the following detailed description, reference is made to theaccompanying drawings that form a part hereof, and in which is shown byway of illustration specific embodiments in which the invention may bepracticed. These embodiments are described in sufficient detail toenable those skilled in the art to practice the invention, and it is tobe understood that the embodiments may be combined, or that otherembodiments may be utilized and that structural, logical and electricalchanges may be made without departing from the scope of the presentinvention. The following detailed description provides examples, and thescope of the present invention is defined by the appended claims andtheir legal equivalents.

It should be noted that references to “an”, “one”, or “various”embodiments in this document are not necessarily to the same embodiment,and such references contemplate more than one embodiment.

In this document, an “indication” includes a symptom or particularcircumstance that indicates the advisability or necessity of a specificmedical treatment or procedure. An “indication for use of an implantablemedical device” or “device indication” includes a symptom or particularcircumstance that indicates the advisability or necessity of one or morespecific medical treatments that are deliverable by an implantablemedical device or one or more specific medical procedures that areperformable by the implantable medical device.

This document discusses an indication-based programming method andprogramming device for an implantable medical device. The programmingdevice collects patient-specific information including a patient'sindications for use of the implantable medical device and automaticallyproduces values for operational parameters enabling the implantablemedical device to deliver one or more therapies according to theindications. In addition to the indications, the patient-specificinformation includes, but is not limited to, the patient's demographicdata, cardiac history, electrogram, electrocardiogram (ECG),echocardiogram (indicative of ejection fraction, for example), physicalattributes, non-cardiac disease history, and/or drug regimens. Furtherexamples of such patient-specific information and an example of a systemfor determining patient-specific parameters for programming animplantable medical device are discussed in U.S. patent application Ser.No. 10/950,876, entitled “SYSTEM AND METHOD FOR DETERMININGPATIENT-SPECIFIC IMPLANTABLE MEDICAL DEVICE PROGRAMMING PARAMETERS,”filed on Sep. 27, 2004, assigned to Cardiac Pacemakers, Inc., which isincorporated herein by reference in its entirety. The patient-specificinformation allows for optimization of therapy delivery for eachindividual patient. The values for the operational parameters producedby the programming device are then used to program the implantablemedical device via telemetry. Thus, the programming device substantiallyautomates the process between the diagnosis of the patient's indicationsand other conditions and the programming of the implantable medicaldevice. The indication-based programming allows a user, such as aphysician or other caregiver, to optimally utilize features andcapabilities of an implantable medical device based on the patient'sspecific conditions.

FIG. 1 is an illustration of an embodiment of a CRM system 100 andportions of the environment in which CRM system 100 is used. System 100includes an implantable medical device 110, a lead system 108, anexternal system 120, and a wireless telemetry link 115.

After implantation, implantable medical device 110 operates within abody 102 to sense activities of a heart 105 and deliver one or moretherapies to heart 105. Implantable medical device 110 includes, but isnot limited to, one or more of a pacemaker, acardioverter/defibrillator, a cardiac resynchronization therapy (CRT)device, a cardiac remodeling control therapy (RCT) device, a drugdelivery device, and a biological therapy device. A device type, such asa model number or a code that identifies the type of implantable medicaldevice 110, indicates one or more available operational modes and aplurality of programmable parameters of implantable medical device 110.Each operational mode provides for one type of therapy deliverable byimplantable medical device 110. In one embodiment, implantable medicaldevice 110 is an implantable cardioverter/defibrillator with pacingcapabilities and providing for operational modes including a bradycardiapacing mode, a CRT pacing mode, an RCT pacing mode, an anti-tachycardiapacing mode, and a defibrillation mode. Some or all of such operationalmodes are further differentiated into specific operational modes. Forexample, the bradycardia pacing mode includes standard pacing modesknown in the art, such as the AOO, VOO, AAI, VVI, VVT, DVI, DDI, VDD,and DDD pacing modes and the rate-adaptive versions of these pacingmodes. Each operational mode is associated with a plurality ofoperational parameters. Values for a set of operational parameters areprogrammed into implantable medical device 110 for it to operate in oneor more operational modes selected according to a patient's conditionsand therapeutic needs.

Lead system 108 provides one or more electrical and/or other connectionsbetween implantable medical device 110 and heart 105. In one embodiment,lead system 108 includes one or more pacing and/or defibrillation leadseach having one or more electrodes for electrogram sensing and/ordelivery of electrical pulses including pacing pulses and/orcardioversion/defibrillation pulses to heart 105. In one embodiment, oneor more intracardiac sensors are incorporated into lead system 108 tosense signals such as heart sounds, intracardiac pressures, and chemicalparameters of the blood.

External system 120 communicates with implantable medical device 110through telemetry link 115. It allows the user and/or the patient tocommunicate with implantable medical device 110. External system 120includes an indication-based programming device 130 that performsindication-based programming of implantable medical device 110. Inaddition to an indication-based programming mode, external system 120also provides for a parameter-based programming mode. When operating inthe indication-based programming mode, indication-based programmingdevice 130 collects patient-specific information and produces the valuesfor the set of operational parameters for programming implantablemedical device 110 to operate in one or more of its availableoperational modes based on the patient-specific information. Whenoperating in the parameter-based programming mode, external system 120presents parameters used in its one or more current operational modeswith their current values and allows the user to adjust the currentvalues. In one embodiment, in addition to the indication-basedprogramming mode and the parameter-based programming mode, externalsystem 120 further provides for a question-based programming mode. Whenoperating in the question-based programming mode, external system 120asks the user a sequence of questions. Based on at least the answers tothese questions, external system 120 determines the values for the setof operational parameters for programming implantable medical device 110to operate in one or more of its operational modes. An example of thequestion-based programming is discussed in U.S. patent application Ser.No. 10/844,642, “METHOD AND APPARATUS FOR QUESTION-BASED PROGRAMMING OFCARDIAC RHYTHM MANAGEMENT DEVICES,” filed on May 13, 2004, assigned toCardiac Pacemakers, Inc., which is incorporated herein by reference inits entirety.

For illustrative purposes, specific embodiments of external system 120are discussed below with reference to FIGS. 2-4. In a specificembodiment, external system 120 includes portions of a system fordetermining patient-specific implantable medical device programmingparameters that is discussed in U.S. patent application Ser. No.10/950,876.

Telemetry link 115 provides for data transmissions between implantablemedical device 110 and external system 120. In one embodiment, telemetrylink 115 is an inductive (magnetic) telemetry link. In anotherembodiment, telemetry link 115 is a far-field radio-frequencyelectromagnetic telemetry link. In various other embodiments, telemetrylink 115 uses other types of media suitable for wireless datatransmissions between an implantable medical device and an externalsystem 120, such as ultrasound. Telemetry link 115 provides for datatransmission from implantable medical device 110 to external system 120.This includes, for example, transmitting information indicative of thedevice type of implantable medical device 110, transmitting dataindicative of the current operational mode(s) and parameter values,transmitting real-time physiological data acquired by implantablemedical device 110, extracting physiological data acquired by and storedin implantable medical device 110, extracting therapy history data,and/or extracting data indicating an operational status (e.g., batterystatus and lead impedance). The physiological data represent signalsacquired by implantable medical device 110 using one or more sensorsincluded in, and/or connected to, implantable medical device 110. In oneembodiment, one or more such sensors are incorporated into lead system108. The signals include, but not being limited to, one or more ofelectrograms, heart sounds or a signal indicative of heart sounds,activity level signal, impedance signal, pressure or pressure-indicatingsignal, and respiratory signal. In one embodiment, the physiologicaldata also include parameters measured from one or more of these signals.In one embodiment, external system 120 or the user determines parametervalues for programming implantable medical device 110 based on thesephysiological data. Telemetry link 115 also provides for datatransmission from external system 120 to implantable medical device 110.This includes, for example, parameters for programming implantablemedical device 110 to operate in one or more of its availableoperational modes and to perform at least one self-diagnostic test (suchas for a battery status or a lead impedance value).

FIG. 2 is a block diagram illustrating an embodiment of portions of thecircuit of an external system 220, which is a specific embodiment ofexternal system 120. External system 220 includes an external telemetrycircuit 222 and an indication-based programming device 230. Externaltelemetry circuit 222 communicates with implantable medical device 110via telemetry link 115.

Indication-based programming device 230 is a specific embodiment ofindication-based programming device 130 and includes a patientinformation input 236, a device information input 238, anindication-based parameter generation module 234, and a programmingmodule 232. Patient information input 236 receives patient-specificinformation including indications for use of the implantable medicaldevice. In various embodiments, patient information input 236 receivespatient-specific information from one or more of implantable medicaldevice 110, another one or more implantable devices implanted in thepatient, sensors externally attached to the patient, a physician orother caregiver through a user interface of external system 220,electronic medical records of the patient stored in one or morelocations in external system 220, and any relevant records madeavailable to external system 220. Device information input 238 receivesdevice-specific information including a device type indicative of aplurality of programmable parameters. In various embodiments, deviceinformation input 238 receives device-specific information fromimplantable medical device 110 and/or one or more locations in externalsystem 220. Indication-based parameter generation module 234 producesvalues for a set of operational parameters of the plurality ofprogrammable parameters based on the patient-specific information andthe device-specific information. Programming module 232 programs theimplantable medical device by converting the values for the set ofoperational parameters into a programming code and causing externaltelemetry circuit 222 to transmit the programming code to implantablemedical device 110 via telemetry link 115.

FIG. 3 is a block diagram illustrating an embodiment of portions of thecircuit of an external system 320, which is a specific embodiment ofexternal system 220. External system 320 includes external telemetrycircuit 222, an indication-based programming device 330, a deviceidentification module 344, a patient information storage system 346, adevice information storage device 350, and a user interface 352.

Indication-based programming device 330 is a specific embodiment ofindication-based programming device 230 and includes patient informationinput 236, device information input 238, an indication-based parametergeneration module 334, and programming module 232. Indication-basedparameter generation module 334 is a specific embodiment ofindication-based parameter generation module 234 and produces values forthe set of operational parameters based on the patient-specificinformation and the device-specific information. The set of operationalparameters enables the implantable medical device to operate in at leastone of its available operational modes. In one embodiment, asillustrated in FIG. 3, indication-based parameter generation module 334includes an operational mode selector 342 and a parameter valuegenerator 340. Operational mode selector 342 selects at least oneoperational mode from the available operational modes of implantablemedical device 110. In one embodiment, operational mode selector 342selects the operational mode(s) based on the patient-specificinformation and the device-specific information. In another embodiment,operational mode selector 342 selects the operational mode(s) based on auser selection and includes a mode input to receive the user selection.Parameter value generator 340 produces the values of the set ofoperational parameters enabling implantable medical device 110 tooperate in the selected operational mode(s) based on thepatient-specific information and the device-specific information. Inanother embodiment, indication-based parameter generation module 334includes an indication-based programming algorithm execution module suchas a mapping algorithm execution module to execute a mapping algorithmrelating the patient-specific information to the device-specificinformation.

Device identification module 344 identifies the device type ofimplantable medical device 110 based on information received by externaltelemetry circuit 222 from implantable medical device 110. The devicetype indicates the available operational modes and the programmableparameters of implantable medical device 110. In one embodiment, deviceidentification module 344 includes a device model identification moduleto identify a model number indicative of the device type. In anotherembodiment, device identification module 344 includes a device codeidentification module to identify a device code indicative of the devicetype.

Patient information storage system 346 includes one or more storagedevices 348 to store patient-specific information including, but notbeing limited to, some or all of indications for use of the implantablemedical device, demographic data, cardiac history, electrogram, ECG,physical attributes, non-cardiac disease history, and drug regimens. Inone embodiment, the patient-specific information is stored as electronicmedical records. In one embodiment, the patient-specific informationincludes information acquired by an outpatient system performingcontinuous monitoring, diagnostic, and patient management functionsincluding continuous ECG monitoring and analysis. Such a system allowscontinuous signal acquisition and/or analysis for a relatively longperiod of time, such as 24 hours or longer. One example of such a systemincludes a Holter monitor, which is known in the art as a portabledevice worn by a patient during the course of daily activities forcontinuously recording cardiac electrical activity of the patient.Another example of such a system is an outpatient mobile telemetrysystem providing for ECG monitoring and analysis used by CardioNet (SanDiego, Calif.) to provide monitoring and patient management services.

Device information storage device 350 stores the device-specificinformation. In one embodiment, device information storage device 350stores device information data sets each specific to one type ofimplantable medical devices programmable by external system 320. Thestored device-specific information is updated when additionalinformation is made available, such as when a new way of using anexisting implantable medical device is developed. In one embodiment,when external system 320 receives additional and/or modified deviceinformation data for an existing type implantable medical device, thedevice information data set stored in device information storage device350 for that existing type implantable medical device is updatedaccordingly.

In one embodiment, upon establishment of telemetry link 115, deviceidentification module 344 identifies the device type of implantablemedical device 110, and the device-specific information is extractedfrom device information storage device 350 according to the identifieddevice type. Device information input 238 then receives the extracteddevice-specific information.

User interface device 352 includes a presentation device 355 and a userinput device 358. Presentation device 355 includes a display screen 354.Display screen 354 includes a parameter field 356 to display the valuesfor the set of operational parameters. In one embodiment, presentationdevice 355 further includes a printer to print information including thevalues for the set of operational parameters. User input device 358includes a programming mode switch 360, an election input device 364, aparameter input device 362, and a programming command input 368.Programming mode switch 360 allows the user to select theindication-based programming mode or the parameter-based programmingmode. In one embodiment, programming mode switch 360 allows the user toswitch between the indication-based programming mode and theparameter-based programming mode during a programming process. Electioninput device 364 allows the user to accept, modify, or discard thevalues for the set of operational parameters. Parameter input device 362allows the user to modify one or more of the values for the set ofoperational parameters if the user has elected to modify the values.Programming command input 368 allows the user to enter a command forprogramming the implantable medical device using the values for the setof operational parameters. In one embodiment, display screen 354 is aninteractive screen that is part of user input device 358. Programmingmode switch 360 includes a programming mode change button displayed onthe interactive screen. Election input device 364 includes electionbuttons displayed on the interactive screen. Parameter field 356 is aninteractive parameter field being part of parameter input device 362.The interactive parameter field allows modification of the displayedvalues for the set of operational parameters. Programming command input368 includes a programming mode change button displayed on theinteractive screen. In another embodiment, one or more of programmingmode switch 360, election input device 364, parameter input device 362,and programming command input 368 includes part of display screen 354,which is an interactive screen, while the remaining input device(s)include switches, keys, knobs, and/or other mechanical devices. Inanother embodiment, programming mode switch 360, election input device364, parameter input device 362, and programming command input 368 eachinclude one or more switches, keys, knobs, and/or other mechanicaldevices.

FIG. 4 is a block diagram illustrating an embodiment of external system420. External system 420 is a specific embodiment of external system 120and, in one embodiment, represents an exemplary structural arrangementfor external system 220 or 320. As illustrated in FIG. 4, externalsystem 420 is a patient management system including an external device370, a telecommunication network 372, and one or more remote devices374. External device 370 is placed within the vicinity of implantablemedical device 110 and communicates with implantable medical device 110via telemetry link 115. Remote device(s) 374 are in one or more remotelocations and communicates with external device 370 throughtelecommunication network 372, thus allowing the user to monitor andtreat the patient from a distant location and/or allowing collection ofpatient information from the one or more remote locations. In onespecific embodiment, external device 370 includes indication-basedprogramming device 130 (including any of its specific embodiment). Inanother specific embodiment, remote device(s) 374 includeindication-based programming device 130 (including any of its specificembodiment). In another embodiment, indication-based programming device130 (including any of its specific embodiments) is distributed in bothexternal device 370 and remote device(s) 374.

Telecommunication network 372 allows for communication between anoperation room, an electrophysiology laboratory, or other facility whereimplantable medical device 110 is programmed and one or more remote datastorage facilities where the patient-specific information is located. Inone embodiment, external system 420 is used during an implantationoperation. External device 370 is placed in or near an operation roomwhere implantable medical device 110 is implanted into a patient. Remotedevice(s) 374 include a data base containing the patient's electronicmedical records. Communication between external device 370 and the database is established to allow indication-based programming device 130 tocollect patient-specific information from the patient's electronicmedical records. Indication-based programming device 130 then generatesa programming code including parameter values required for implantablemedical device 110 to deliver one or more therapies approximatelyoptimized based on the patient-specific information. Thus, externalsystem 420 provides for a substantially automated process forprogramming implantable medical device 110 during the implantationoperation.

FIG. 5 is a flow chart illustrating an embodiment of a method for anindication-based programming of an implantable medical device. Themethod substantially automates the process between the diagnosis of apatient and the programming of the implantable medical device if thepatient is indicated for a device therapy as the result of thediagnosis. In one embodiment, the method is performed with externalsystem 220.

Patient-specific information is collected at 500. The patient-specificinformation includes indications for use of the implantable medicaldevice. An indication-based automatic programming algorithm is executedat 510 to produce values for a set of operational parameters based onthe patient-specific information. The set of operational parametersenables the implantable medical device to deliver one or more therapiestreating the patient's indications. The implantable medical device isprogrammed using the values for the set of operational parameters at520. In one embodiment, the implantable device is automaticallyprogrammed after the values for the set of operational parameters areproduced. In another embodiment, after the values for the set ofoperational parameters are produced, the user reviews the values,modifies the values when appropriate or necessary, and the implantablemedical device is then programmed.

FIG. 6 is a flow chart illustrating a specific embodiment of the methodfor the indication-based programming of the implantable medical device.In one embodiment, the method is performed with external system 320. Theimplantable medical device includes, but is not limited to, a pacemaker,a cardioverter/defibrillator, a CRT device, and an RCT device.

Patient-specific information is collected at 600. In one embodiment, thepatient-specific information includes indications for use of theimplantable medical device. In a further embodiment, in addition to theindications for use of the implantable medical device, thepatient-specific information includes one or more of demographic data,cardiac history, electrogram, ECG, echocardiogram, physical attributes,non-cardiac disease history, and drug regimens. In one embodiment,collecting the patient-specific information includes extractinginformation from an electronic medical record. In one embodiment,collecting the patient-specific information includes extractinginformation from results of one or more electrophysiological tests. Inone embodiment, collecting the patient-specific information includesextracting information from the implantable medical device.

Device-specific information is received at 610. The device-specificinformation includes a device type of the implantable medical device.The device type indicates the available operational modes and theprogrammable parameters of the implantable medical device. Eachoperational mode is supported by a set of operational parametersincluding one or more of the programmable parameters.

An indication-based programming algorithm is executed at 620 to producevalues for the set of operational parameters based on thepatient-specific information and the device-specific information. In oneembodiment, the indication-based programming algorithm automaticallyselects one or more operational modes from the available operationalmodes of the implantable medical device based on the patient-specificinformation and the device-specific information. The values for the setof operational parameters are then produced to enable the implantablemedical device to operate in the automatically selected operationalmode(s). In another embodiment, the user selects one or more operationalmodes from the available operational modes of the implantable medicaldevice based on the patient-specific information, the device-specificinformation, and professional judgment. The values for the set ofoperational parameters are then produced to enable the implantablemedical device to operate in the user-selected operational mode(s). Inone embodiment, the indication-based programming algorithm is a mappingalgorithm relating the patient-specific information to thedevice-specific information of the implantable medical device. Themapping algorithm selects one or more operational modes from theavailable operational modes of the implantable medical device and/orproduces the values for the set of operational parameters enabling theimplantable medical device to operate in the selected operationalmode(s).

A user election regarding the handling of the values for the set ofoperational parameters is received at 630. In one embodiment, the valuesfor the set of operational parameters are presented to the user forreview. The user is then asked to elect to accept, modify, or discardthe values for the set of operational parameters. If an election toaccept the values for the set of operational parameters is received at640, the implantable medical device is programmed using the values forthe set of operational parameters at 660. If an election to modify thevalues for the set of operational parameters is received at 640, one ormore modified values for the set of operational parameters are receivedat 650. In one embodiment, the received one or more modified values arechecked against one or more predetermined safety limits. If any modifiedvalue for an operational parameter exceeds the predetermined safetylimit for that parameter, the user is asked to reenter the value forthat parameter. In another embodiment, the one or more modified valuesare entered by selecting values and/or value ranges presented to theuser. The presented values and/or value ranges are within thepredetermined safety limits. Then, the implantable medical device isprogrammed using the one or more modified values for the set ofoperational parameters at 660. If an election to discard the values forthe set of operational parameters is received at 640, a new programmingprocess is started at 670. The user may, for example, choose to repeatthe steps starting at 600 after making additional and/or alternativepatient-specific information available for collection. The user may alsochoose to switch to the parameter-based programming mode or thequestion-based programming mode.

In one exemplary application of the indication-based programming, apatient's electronic medical record is reviewed to determine whether thepatient is indicated for use of an implantablecardioverter/defibrillator (ICD) based on criteria developed fromresults of a clinical study with a patient population. Examples of sucha clinical study are discussed in Prystowsky, “A Guide to DeviceSelection: Cardiac Resynchronization Therapy Alone or in Combinationwith an Implantable Cardioverter Defibrillator,” Rev. Cardiovasc. Med.,2003; 4(Suppl 2): (S47-S54). The ICD is capable of delivering pacing andcardioversion/defibrillation therapies. If the patient is indicated forboth ventricular defibrillation therapy and anti-tachycardia pacing(ATP) therapy, data from an electrophysiology test and Holter recordingsare analyzed. The analysis results in, among other things, a thresholdheart rate above which the ventricular defibrillation therapy is to beimmediately delivered and another threshold heart rate above which anATP therapy is to be delivered. The analysis may also result ininformation related to the morphological features of an electrogramassociated with a known cardiac rhythm for purposes of discriminationbetween various types of arrhythmia. The discrimination leads toclassification of a tachyarrhythmia, and an appropriate therapy isdelivered according to the classification. If the electronic medicalrecords further indicate that the patient has a family history ofsyncope, a monitoring zone is set at lower heart rates to captureepisodes of slow ventricular tachycardia in order to determine whetherthe syncope is cardiac mediated.

It is to be understood that the above detailed description is intendedto be illustrative, and not restrictive. For example, while a CRM systemis specifically discussed in the description above, the present subjectmatter is generally applicable to various types of medical devicesystems. Other embodiments will be apparent to those of skill in the artupon reading and understanding the above description. The scope of theinvention should, therefore, be determined with reference to theappended claims, along with the full scope of equivalents to which suchclaims are entitled.

1. An external system for programming an implantable medical device, thesystem comprising: a telemetry circuit configured to receive informationfrom the implantable medical device; a device identification moduleconfigured to identify the device type of the implantable medical deviceusing information received from the implantable medical device viatelemetry; a programming device configured to receive patient-specificinformation and the identified device type, the programming devicecomprising: an operational mode selector configured to select at leastone operational mode of the implantable medical device based on thepatient-specific information and the identified device type; and aparameter value generator configured to automatically produce values ofa set of operational parameters enabling the implantable medical deviceto operate in the selected operational mode using the patient-specificinformation and the identified device type; and a display screenconfigured to display the values of the set of operational parameters.2. The system of claim 1, further comprising an election input deviceconfigured to receive a user election to accept and a user election todiscard the values of operational parameters.
 3. The system of claim 2,wherein the election input device is further configured to receive auser election to modify the automatically produced values of a set ofoperational parameters.
 4. The system of claim 3, wherein the displayscreen is configured to present the user with one or more rangesencompassing one or more operational parameter values alternative to theautomatically produced values upon receiving an election to modify theautomatically produced values, wherein the one or more alternativeoperational parameter values encompassed by the one or more ranges arewithin predetermined safety limits.
 5. The system of claim 1, whereinthe programming device is configured to program an implantablepacemaker.
 6. The system of claim 5, wherein the programming device isfurther configured to program an implantable cardioverter/defibrillator.7. The system of claim 1, wherein the operational mode selector isfurther configured to select an operational mode from a plurality ofavailable operational modes of the implantable medical device based on auser selection, the operational mode selector including a mode inputconfigured to receive the user selection.
 8. The system of claim 1,further comprising: a telecommunication network; and one or more storagedevices configured to store the patient-specific information andincluding at least one storage device coupled to the programming devicevia the telecommunication network.
 9. The system of claim 1, wherein thepatient-specific information comprises electronic medical records of thepatient, the electronic medical records defining a symptom orcircumstance that indicates advisability of one or more medicaltreatments deliverable by the implantable medical device.
 10. The systemof claim 1, wherein the device type defines the set of operationalparameters.
 11. A method for programming an implantable medical devicefor a patient, the method comprising: receiving device-specificinformation indicative of a device type of the implantable medicaldevice from the implantable medical device via a telemetry link;collecting patient-specific information; selecting at least oneoperational mode of the implantable medical device based on thepatient-specific information and the device specific information; andautomatically producing values of a set of operational parametersenabling the implantable medical device to operate in the selectedoperational mode by using the patient-specific information and thedevice specific information.
 12. The method of claim 11, furthercomprising programming the implantable medical device.
 13. The method ofclaim 12, wherein programming the implantable medical device comprisesprogramming at least one of the group consisting of an implantablecardioverter/defibrillator and an implantable pacemaker.
 14. The methodof claim 11, wherein collecting the patient-specific informationcomprises collecting information acquired by an outpatient systemperforming continuous patient monitoring.
 15. The method of claim 11,wherein collecting the patient-specific information comprises collectinginformation from at least one storage device via a telecommunicationnetwork.
 16. The method of claim 11, wherein selecting the operationalmode further comprises receiving a selection from a user.
 17. The methodof claim 11, further comprising providing a user an option to accept andan option to discard the values of the set of operational parameters.18. The method of claim 11, wherein the patient specific informationcomprises electronic medical records of the patient, the electronicmedical records defining a symptom or circumstance that indicatesadvisability of one or more medical treatments deliverable by theimplantable medical device.
 19. The method of claim 11, furthercomprising presenting a user with an option to accept, modify, ordiscard the automatically produced values of the set of operationalparameters.
 20. The method of claim 11, further comprising receiving auser election to modify the automatically produced values; and inresponse to receiving the election, presenting the user with one or moreranges encompassing one or more alternative operational parameter valuesthat are within predetermined safety limits.